Laboratories that analyze the function and/or the phenotype of white blood cells (lymphocytes/leukocytes) comprising the immune system are surveyed and permitted through the Clinical Laboratory Evaluation Program (CLEP). 

Permit Category Descriptions [2] are provided. 

Laboratories are required to demonstrate compliance with:

• General Systems Standards - Effective August 2020 [3]
• Cellular Immunology and Cytokines - Effective August 2020 [4]

For method approval [5] and validations, please return the completed Cellular Immunology Checklist [6] to the address indicated on the form.